San Diego County Announces Pause Of Johnson & Johnson Vaccine

Speaker 1: 00:00 San Diego County announced today. It is pausing the use of the Johnson and Johnson COVID-19 vaccine out of an abundance of caution. This follows guidance from the U S centers for disease control and prevention and the food and drug administration. The agencies are reviewing reports of a rare and severe type of blood clot that occurred in six people in the U S after receiving the Johnson and Johnson vaccine. Joining me to talk about this new development is the San Diego union Tribune biotech reporter, Jonathan Rosen. Jonathan, welcome. Thank you for having me. So what more has the CDC and the FDA said about the blood clots that were reported? Speaker 2: 00:38 So here, here's what we know. And at this point it's a little bit limited because those agencies put out their statement early this morning, but basically we know that there were six women between the ages of 18 and 48 years old, who between six to 13 days after getting their vaccine, um, you know, showed signs of blood clotting and the veins that drain the brain and that they also had low platelet counts. You know, we don't know quite how extensive their symptoms were and if they've begun to recover, what kind of care they're getting. But basically that was enough for both of these agencies to say, we need to take a closer look at what's going on and to attempt to temporarily recommend pausing the rollout of the vaccine, both nationally, and then we've seen state and local officials say the same. So that's basically what we know at this stage. Speaker 1: 01:31 Have there been any reports of problems with blood clots, following a Johnson and Johnson vaccine here in San Diego County? Speaker 2: 01:37 Yeah, that's a good question. So I don't know if the six women who had these symptoms had this illness, uh, if any of them were connected to San Diego County in any way, we, we don't immediately know how many doses of Johnson, Johnson vaccine, uh, have been shipped and actually used here. You know, it certainly must be in the thousands. We know that the County has made that vaccine available for the general population of eligible San Diego, but also in particular for people who are either homeless or people who are farm workers, folks who might benefit from not having to come back for a second shot. So this is the one vaccine, that's a one-shot vaccine. Uh, we know that at least a couple hundred San Diego took part in the clinical trial, uh, which it was being led out of UC San Diego and is ongoing. And I'll be speaking with the person who's directing that trial later this afternoon, but we haven't heard about any issues like that from this trial. Uh, but I think this kind of underscores a point, which is that clinical trials test a vaccine and tens of thousands of people. But when you actually use it on millions of people across the world, you may find rare side effects, uh, that you don't pick up in those initial studies. Speaker 1: 02:52 What else do we know about the individuals who experienced those blood clots? Were they at a higher risk? So that's unclear Speaker 2: 03:00 Whether or not they were genetically or medically predisposed. We really don't know much beyond their general age range and the fact that these were all women. Um, this is also, you know, just six people that we're talking about and roughly 6.8 million people have gotten the vaccine here in the U S so that, that might add up to a rate of about one per million, although it's possible that we'll see more cases emerge now that the FDA and CDC have flagged this as something of interest. So really we just have limited information and we'll probably hear more today as well as tomorrow. So the CDCs advisory committee on immunization practices, which issues recommendations on what groups of people should get certain vaccines that are going to be meeting tomorrow, uh, the state of California, as well as some other Western States has a safety review board. That's going to be meeting either today and tomorrow. And they're going to be looking at, uh, you know, the sort of details around the medical history and severity of his symptoms. So we should get a little more clarity there, but we don't have too much right now. Speaker 1: 04:04 You know, you just put into perspective how rare these blood clots are. Uh, with that in mind, do you have a sense of why the CDC has made the decision to advise pausing the use of the Johnson and Johnson vaccine? Speaker 2: 04:16 So I think one major factor is what's going on in Europe with the AstraZeneca vaccine. You know, there've been some cloth, some cases, excuse me, of blood clots among people. Who've gotten that vaccine at roughly a rate of one per every 300,000 people. And actually their version of the FDA, the European medicine agency said last week that there could be a real link there between that vaccine and blood clots and the types of blood clots. They were reporting at least on surface passing to be similar to what's happening here with some of the people who've gotten the J and J vaccine. So there is precedent lately for a real but rare link between blood clots and these two vaccines, both of these vaccines use what's called a viral vector approach. So they use a common cold virus. That's been modified to be safe, to deliver genetic instructions, uh, against the Corona virus to start immunity. So it's a similar type of design and we're hearing similar reports, uh, in both cases that are really low frequency, but I think that they just want to make sure that they're taking the time to see how common is the risk, and if they need to issue any different recommendations in terms of, you know, who should be getting this vaccine. Speaker 1: 05:33 And for people who may have just gotten the Johnson and Johnson vaccine, what are the severe side effects that could indicate a possible blood clot? Speaker 2: 05:41 Right? So the FDA and CDC are asking anyone who is developing a severe headache or severe abdominal pain or leg pain, or shortness of breath within three weeks of getting the vaccine to contact their healthcare provider that may not necessarily be assigned. They have a blood clot, but it's just something that they want people to be aware of. Um, you know, in the, in the first couple of weeks after getting that shot. So those would be the things to keep an eye out for. You know, of course these vaccines, you know, commonly leave you people feeling a little achy. It's not uncommon at all to have headache after your shot and from what, from what we're seeing so far, these are extremely, uh, extremely rare side effects. Uh, and we can compare that to the rate of COVID-19 infection and COVID symptoms. So I don't think it's cause for alarm, but yeah, certainly it's worth just keeping track of how you're feeling in the weeks after you get your shot. Speaker 1: 06:40 So how are physicians being advised to handle potential side effects from the vaccine? I mean, what are they telling patients? Speaker 2: 06:47 Right. So the, the one announcement that is important for physicians here is that these blood clots, unlike standard blood clots, uh, shouldn't be treated with heparin, which is a common anticoagulant, common blood clot treatment. So I think part of the reason why the CDC and FDA moved quickly to make this announcement was to put healthcare providers on notice that if they are seeing new symptoms and people who've been vaccinated with this vaccine to make sure that they're using a different type of a blood clot treatment versus the typical standard here. Speaker 1: 07:23 Hmm. And how long do you expect we will have to wait before knowing more about the possible dangers of the Johnson and Johnson vaccine. Speaker 2: 07:30 So, um, I expect that we will get some more information tomorrow out of the CDCs advisory committee meeting. You know, I spoke with Dr. Mark Sawyer, who is an infectious disease expert or Rady children's hospital this morning. And, you know, he pointed out that 24 hours really, isn't going to be enough time to get clarity in terms of exactly what's going on here. You know, I think with the AstraZeneca case in Europe, within a couple of weeks, we had a good sense of whether or not the blood clots were really linked to the vaccine. I suspect here it might be a similar timeline or, uh, maybe a bit shorter than that. So I would say within the next several days to the next week or so, we may get a little more clarity on exactly how common these symptoms are and how strongly they're linked, if at all, to the J and J bag. Speaker 1: 08:23 I've been speaking with San Diego union Tribune, biotech reporter, Jonathan Rosen, Jonathan, thank you very much. My pleasure. Speaker 3: 08:40 [inaudible].